FDA Adverse Event
Injury
Summary report: N
SPRINT
MDR report key: 2813225
·
Received October 31, 2012
Report
- Report Number
- 2182208-2012-03777
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S13
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A LEAD INTEGRITY ALERT TRIGGERED AND THERE WAS NOISE AND OVERSENSING NOTED IN BOTH THE ATRIAL AND VENTRICULAR CHAMBERS. SEVERAL OF THE EVENTS ON BOTH THE ATRIAL AND VENTRICULAR LEADS LOOKED LIKE ELECTROMAGNETIC INTERFERENCE AND SOME OF THE EVENTS ON THE RIGHT ATRIAL LEAD LOOKED LIKE POSSIBLE CONDUCTOR FAILURE. THE HIGH VOLTAGE THERAPIES WERE TURNED OFF AND BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC, INC. | 6943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |